Feature sponsored by Test & measurement
Figure 4. Secure electronic authentication from ADI.
the cartridge that changes shape or position once inserted into the instrument. Such mechanical features provide a simple means of preventing reuse that can be implemented at a low cost into the system. They are however identical cartridge to cartridge, hence providing no means of distinguishing one patient sample from another. They are visible to the user and are typically easy to copy, making the design prone to counterfeiting. Mechanical features can also be reset when used kits are refurbished by an unauthorised party. As PoC devices shrink, adding a mechanical feature to the cartridge poses an additional design burden.
WHAT IS ELECTRONIC AUTHENTICATION AND HOW IS IT IMPROVING POC TESTING RESULTS? Finding an ideal solution for the PoC market involves looking beyond these traditional methods to electronic authentication in the form of an IC that can be integrated into the cartridge. An electronic authentication IC provides a robust means of preventing both cartridge reuse and misuse. Firstly, to address reuse, electronic authenticator ICs contain secure decrement counters that ensure single- use cartridges are only processed once. An integrated numeric unique ID identifies one patient sample from another. The potential for misuse is also addressed with the integration of cryptographic-based challenge-response
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algorithms that prevent third-party manufacturers from creating counterfeit cartridges. Secure authenticator ICs provide additional features, such as the ability to securely record usage history in the form of a timestamp. This can be valuable when tests need to be run frequently or at specific times each day.
Unlike barcodes and mechanical features, electronic authenticator solutions are integrated inside the cartridge, making the security solution invisible to users and potential counterfeiters. A compact IC also reduces design challenges associated with the size constraints of a compact PoC instrument. By adopting an electronic authenticator IC, the risk of reuse and misuse of sample cartridges is greatly reduced, providing patients and device manufacturers a level of assurance that the testing results are authentic and can be trusted.
ELECTRONIC AUTHENTICATION SOLUTIONS FROM ANALOG DEVICES Analog Devices’ portfolio of electronic authenticator ICs provides a turnkey solution that can be easily integrated into a PoC cartridge without extensive knowledge of cryptographic technology.
Each secure authenticator IC has a unique 64- bit serial number for secure identification and traceability of the cartridge or device. The secure memory safeguards sensitive data including manufacturing information or calibration
parameters and prevents tampering. The authentication features industry-standard symmetric key SHA-2/SHA-3, or asymmetric key ECDSA crypto algorithms to ensure the cartridges are genuine and prevent the use of third-party counterfeits. An integrated, secure, decrement- only counter simplifies use management and prevents the reuse of the disposable cartridge. Key products for the PoC application include the DS28E16, which uses a simple 1-Wire communication interface, and the MAX66250 with an NFC contactless interface. ADI’s electronic authenticator ICs can be integrated into a design without the need for a dedicated PCB, providing a solution that eases compact PoC design.
CONCLUSION The rise of PoC testing is driving the need for greater security and traceability of patient samples. Device miniaturisation along with the heightened risk factors associated with PoC testing is challenging traditional means of patient sample tracking, such as the use of tracking barcodes popular in lab settings. An electronic authentication IC, such as the DS28E16 from ADI, will ease the design of PoC instruments and help device manufacturers mitigate security risks, reducing the potential of misdiagnosis, delayed diagnosis, or product recall.
Analog Devices
www.analog.com August 2023 Instrumentation Monthly
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